Table 6.
Stability of SH-1242 QC samples under typical storage conditions.
| Batch | Rat Plasma | Mouse Plasma | ||||
|---|---|---|---|---|---|---|
| Theoretical Concentration (ng/mL) | Theoretical Concentration (ng/mL) | |||||
| LQC | MQC | HQC | LQC | MQC | HQC | |
| 2 | 40 | 800 | 4 | 40 | 800 | |
| Benchtop stability at room temperature (25 °C) for 24 h (n = 3) | ||||||
| Mean | 1.87 | 37.3 | 737 | 4.21 | 41.7 | 810 |
| Precision (CV%) a | 6.95 | 4.35 | 2.62 | 9.47 | 4.38 | 5.57 |
| Accuracy (RE%) b | –6.33 | –6.83 | –7.88 | 5.25 | 4.25 | 1.25 |
| Autosampler stability at 4 °C for 3 days (n = 3) | ||||||
| Mean | 2.00 | 38.9 | 773 | 4.19 | 42.6 | 863 |
| Precision (CV%) | 8.27 | 6.05 | 3.16 | 4.90 | 5.15 | 0.699 |
| Accuracy (RE%) | –0.167 | –2.75 | –3.33 | 4.67 | 6.50 | 7.83 |
| Freeze-thaw stability (3 cycles, n = 3) | ||||||
| Mean | 1.84 | 41.97 | 780 | 4.45 | 42.4 | 840 |
| Precision (CV%) | 3.85 | 4.20 | 3.57 | 2.00 | 4.32 | 1.33 |
| Accuracy (RE%) | –7.83 | 4.92 | –2.50 | 11.3 | 6.00 | 5.00 |
| Long term stability at 4 °C for 2 weeks (n = 3) | ||||||
| Mean | 2.02 | 37.3 | 730 | 3.84 | 44.8 | 865 |
| Precision (CV%) | 8.54 | 2.56 | 0.825 | 12.0 | 1.77 | 4.37 |
| Accuracy (RE%) | 0.833 | –6.75 | –8.71 | –4.08 | 12.0 | 8.08 |
a CV(%) = (standard deviation/mean) × 100. b RE(%) = [(calculated concentration – theoretical concentration)/theoretical concentration] × 100.